IMPLANTABLE VASCULAR DEVICE

• US 20090157169A1
• Filed: 02/26/2009
• Published: 06/18/2009
• Est. Priority Date: 06/02/1998
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Bates, Brian L., Dixon, Christopher G., Hoffa, Andrew K., Osborne, Thomas A., Keller, Frederick S., Rosch, Josef, Obermiller, Joseph F., Roberts, Joseph W., DeFord, John A., Leonard, Raymond B. II
• Granted Patent: US 8,444,687 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Claims

1. A medical product, comprising:

a stentless valve having a plurality of membranes free from any separate support frame, the plurality of membranes implantable in a body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen; and

an endoluminally advanceable delivery device having an expandable member upon which said stentless valve is mounted, the expandable member configured for expansion in the lumen for forcing the valve against the wall of the lumen for delivery of the valve.

2. The medical product of claim 1, wherein said membranes are configured to flex in response to fluid flow in the body lumen.

3. The medical product of claim 1, wherein said membranes are configured to invert their shape in response to fluid flow in the body lumen.

4. The medical product of claim 3, wherein said inversion in shape is relative to the radial axis of the body lumen.

5. The medical product of claim 1, wherein the membranes are formed of a polymer.

6. The medical product of claim 5, wherein the polymer is polytetrafluoroethylene.

7. The medical product of claim 5, wherein the membranes are formed of Dacron.

8. The medical product of claim 1, wherein the membranes are formed of a collagenous material.

9. The medical product of claim 1, comprising two membranes.

10. The medical product of claim 1, wherein the membranes are generally triangular in shape.

11. The medical product of claim 1, wherein the valve lacks radial expandability sufficient to anchor itself to the wall of the body lumen.

12. The medical product of claim 1, wherein the expandable member is a balloon.

13. The medical product of claim 1 also comprising one or more barbs attached to the stentless valve for embedding in a wall of the body lumen.

14. A method of treating a patient, comprising:

delivering a medical product to a body lumen, the product including a stentless valve and further a catheter having an expandable member upon which the stentless valve is mounted, the stentless valve having a plurality of membranes free from any separate support frame, the plurality of membranes implantable in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen;

expanding the expandable member in the body lumen so as to force the valve against a wall of the body lumen; and

removing the catheter from the body lumen such that the valve remains anchored in the body lumen in the absence of a stent.

15. The method of claim 14, wherein the expandable member is a balloon.

16. The method of claim 14, wherein the anchored valve includes one or more barbs extending into a wall of the body lumen.

17. A medical product, comprising:

a balloon catheter;

a stentless valve removably mounted on the balloon catheter for percutaneous introduction into a body lumen of a patient, the valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen; and

one or more barbs attached to the stentless valve, wherein the balloon catheter is configured to expand in the body lumen to force the stentless valve against the wall of the lumen such that the one or more barbs become embedded in the wall to anchor the valve in the body lumen in the absence of a stent.

18. A method of controlling flow in a body lumen, the method comprising:

forcing a membrane of a stentless valve against a wall of a body lumen with a balloon such that a barb attached to the membrane extends into the wall and anchors the membrane in the body lumen in the absence of a stent, wherein the anchored membrane is thereupon moveable between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional membranes, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional membranes.

19. The method of claim 18, wherein the membrane in said second position and a portion of the body lumen form a cup for trapping the fluid.

20. The method of claim 18, comprising forcing a plurality of membranes of a stentless valve against a wall of a body lumen with a balloon such that one or more barbs attached to the plurality of membranes extends into the wall and anchors the plurality of membranes in the body lumen in the absence of a stent, wherein the anchored membranes are thereupon movable between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membranes in said first position restrict fluid flow through the lumen in a first direction, and wherein said membranes in said second position permit fluid flow through the lumen in the first direction.

21. A method of controlling flow in a body lumen, the method comprising:

moving a membrane of a valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein the valve is percutaneously implanted in the body lumen and is free from any separate support frame, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional leaflets, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional leaflets.

22. A method for treating a patient comprising:

providing a percutaneously implanted valve anchored in a body lumen of the patient in the absence of a stent, the percutaneously implanted valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen.

23. The method of claim 22, wherein the valve is anchored in the body lumen by barbs extending into the vessel wall.

24. The method of claim 22, wherein the valve lacks any separate support frame.

25. The method of claim 22, wherein the valve comprises a frame integral with said leaflets.

26. The method of claim 22, wherein said valve lacks any separate support frame and said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.